FDA Unveils Clinical Trial Diversity Tools

FDA Headquarters

As part of its ongoing effort to encourage patient diversity in clinical trials, the U.S. Food and Drug Administration (FDA) has just released a wide array of resources designed to help promote female participation in trials.

The new resources include a social media toolkit, clinical trial fact sheets in English and Spanish, consumer updates on clinical trials, and a January 24 webinar addressing the collection of race and ethnicity data in trials.

FDA uses the new materials to address several important issues, including why women should participate in trials, important things to understand before participating, how the informed consent process works, where to find a trial, and how to help spread the word.

Last year the agency significantly stepped up its efforts to broaden participation in clinical trials. The agency takes the effort seriously; to help make certain the most complete picture possible is available of the risk or benefit of a medical product, patients enrolled in a trial should be representative of the types of patients who are likely to use the medical product if it is approved or cleared by the FDA.

Register for FDA’s upcoming webinar on the Collection of Race and Ethnicity Data in Clinical Trials, scheduled for Tuesday, January 24, 2017 at 12 p.m. EST.

Certain populations can be more at risk for certain diseases—such as diabetes and heart disease—than others. “It is important for patients in those populations who are more likely to be treated for a condition to be included in a trial,” the agency said.

“ACRP is committed to helping increase participation in clinical trials,” says ACRP Executive Director Jim Kremidas.

ACRP has helped spread the word by conducting a webinar series in conjunction with FDA and by sharing FDA resources.

Announced by FDA today:


More Resources

Check out the following replays of ACRP’s Diverse Women in Clinical Trials Webinar Series in conjunction with FDA: